BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIESHABER REVOLUTION DSP FORCEPS

    MDR report key: 11738578 · Received April 28, 2021

    Report

    Report Number
    3003398873-2021-00029
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    April 13, 2021
    Report Date
    June 14, 2021
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HNR
    UDI-DI
    07612717071148
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE FORCEPS SAMPLE WAS RECEIVED IN AN INNER BLISTER INCLUDING THE COVER FOIL. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. THE RETURNED SAMPLE WAS FUNCTIONALLY AND VISUALLY INSPECTED WITH THE AID OF A PHOTOMICROSCOPE WITH VARIOUS MAGNIFICATIONS. THE SAMPLE SHOWS SURGERY RESIDUALS. THE CUSTOMER¿S COMPLAINT WAS NOT CONFIRMED. IT WAS FOUND THAT THE FORCEPS COULD BE ACTIVATED AND THE OPENING AND CLOSING WAS GOOD. A ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE RETURNED SAMPLE MEETS THE SPECIFICATIONS. NO CORRECTIVE ACTIONS ARE REQUIRED BECAUSE THERE IS NO INDICATION OF A MALFUNCTION. THIS COMPLAINT HAS BEEN REVIEWED AND FUTURE DATA WILL BE MONITORED FOR EVIDENCE OF ADVERSE TRENDING WITH FURTHER ACTION TAKEN, AS APPROPRIATE. AT A MINIMUM, THIS WILL INCLUDE COMPLETING REVIEWS OF COMPLAINT CLASS REPORT LEVELS ON A MONTHLY BASIS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE THAT HAS NOT YET BEEN RECEIVED AT MANUFACTURING FOR EVALUATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT THE TIPS OF AN OPHTHALMIC FORCEPS FAILED TO OPEN AND CLOSE DURING A COMBINATION CATARACT AND VITRECTOMY SURGERY. AN ALTERNATE FORCEPS WAS OBTAINED IN ORDER TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633275 GRIESHABER REVOLUTION DSP FORCEPS FORCEPS, OPHTHALMIC HNR ALCON GRIESHABER AG NA F200390 07612717071148

    Patients

    Seq Age Sex Outcome Treatment
    1